CDC COVID-19 Vaccine Pregnancy Registry: Design, data collection, response rates, and cohort description.

The U.S. Centers for Disease Control and Prevention (CDC) developed and implemented the CDC COVID-19 Vaccine Pregnancy Registry (C19VPR) to monitor vaccine safety. Potential participants who received a COVID-19 vaccine in pregnancy or up to 30 days prior to their pregnancy-associated last menstrual period were eligible to participate in the registry, which monitored health outcomes of participants and their infants through phone interviews and review of available medical records. Data for select outcomes, including birth defects, were reviewed by clinicians. In certain cases, medical records were used to confirm and add detail to participant-reported health conditions. This paper serves as a description of CDC C19VPR protocol. We describe the development and implementation for each data collection aspect of the registry (i.e., participant phone interviews, clinical review, and medical record abstraction), data management, and strengths and limitations. We also describe the demographics and vaccinations received among eligible and enrolled participants. There were 123,609 potential participants 18-54 years of age identified from January 2021 through mid-June 2021; 23,339 were eligible and enrolled into the registry. Among these, 85.3 % consented to medical record review for themselves and/or their infants. Participants were majority non-Hispanic White (79.1 %), residents of urban areas (93.3 %), and 48.3 % were between 30 and 34 years of age. Most participants completed the primary series of vaccination by the end of pregnancy (89.7 %). Many participants were healthcare personnel (44.8 %), possibly due to the phased roll-out of the vaccination program. The registry continues to provide important information about the safety of COVID-19 vaccination among pregnant people, a population with higher risk of poor outcomes from COVID-19 who were not included in pre-authorization clinical trials. Lessons learned from the registry may guide development and implementation of future vaccine safety monitoring efforts for pregnant people and their infants.

Risk Factors for Human Papillomavirus-Associated Cancers Among People Living with HIV in Washington, District of Columbia.

District of Columbia (DC) has high rates of HIV infection and human papillomavirus (HPV)-associated cancers. People living with HIV (PLWH) are at risk for developing HPV-associated cancers. Previous studies identified factors that may further increase the risk of HPV-associated cancer among PLWH such as age, race/ethnicity, sex, risk factor for HIV transmission, stage of HIV infection, and age at HIV diagnosis. The extent to which PLWH in DC are affected by HPV-associated cancers has not previously been well described, and to our knowledge, the relationship between bacterial sexually transmitted infections (STIs) and subsequent development of HPV-associated cancer among PLWH in DC has not been explored. This was a retrospective case-control analysis of surveillance data on cancer, STIs, and HIV in Washington, DC from 1996 to 2015. There were 20,744 PLWH included in this study, of whom 335 (1.6%) had been diagnosed with an HPV-associated cancer. Among males living with HIV (MLWH), for every additional STI per 10 person-years, risk of developing an HPV-associated cancer increased by 11%. Exposure to STIs was not a significant risk factor for HPV-associated cancer among females. Ever being diagnosed with stage three HIV infection increased risk of HPV-associated cancers among males by 109% and females living with HIV by 111%. STI exposures were associated with HPV-associated cancers among MLWH in DC and ever being diagnosed with advanced HIV infection was associated with HPV-associated cancers among all PLWH. Clinicians treating MLWH should ensure their patients receive primary HPV infection prevention and HPV-associated cancer screenings.

Investigation of a Candida auris outbreak in a skilled nursing facility - Virginia, United States, October 2020-June 2021.

Candida auris, an emerging multi-drug resistant organism, is an urgent public health threat. We report on a C. auris outbreak investigation at a Virginia ventilator skilled nursing facility. During October 2020-June 2021, we identified 28 cases among residents in the ventilator unit. Genomic evidence suggested ≥2 distinct C. auris introductions to the facility. We identified multiple infection and prevention control challenges, highlighting the importance of strengthening multi-drug resistant organism prevention efforts at ventilator skilled nursing facilities.

Effectiveness of Coronavirus Disease 2019 (COVID-19) mRNA Vaccines Against Infection During an Outbreak of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Beta (B.1.351) Variant in a Skilled Nursing Facility: Virginia, March-April 2021.

In April 2021, we assessed mRNA vaccine effectiveness (VE) in the context of a COVID-19 outbreak in a skilled nursing facility. Among 28 cases, genomic sequencing was performed on 4 specimens on 4 different patients, and all were classified by sequence analysis as the Beta (B.1.351) variant. Adjusted VE among residents was 65% (95% confidence interval: 25-84%). These findings underscore the importance of vaccination for prevention of COVID-19 in skilled nursing facilities.

Psychosocial stress and neuroendocrine biomarker concentrations among women living with or without HIV.

OBJECTIVE: Women living with HIV (WLWH) experience psychosocial stress related to social-structural vulnerabilities. To investigate neuroendocrine pathways linking stress and increased cardiovascular disease risk among WLWH, we evaluated associations between psychosocial stress (i.e., perceived stress, posttraumatic stress, and experiences of race- and gender-based harassment) and a composite neuroendocrine biomarker index among WLWH and women without HIV. METHODS: In 2019-2020, Women's Interagency HIV Study participants in Washington, DC completed a questionnaire and provided blood and 12-hour overnight urine samples for testing of serum dehydroepiandrosterone sulfate (DHEA-S) and urinary free cortisol, epinephrine, and norepinephrine. Psychosocial stress was measured using the Perceived Stress Scale, PTSD Checklist-Civilian Version, and Racialized Sexual Harassment Scale. Latent profile analysis was used to classify participants into low (38%), moderate (44%), and high (18%) stress groups. Composite biomarker index scores between 0-4 were assigned based on participants' number of neuroendocrine biomarkers in high-risk quartiles (≥75th percentile for cortisol, epinephrine, and norepinephrine and ≤25th percentile for DHEA-S). We evaluated associations between latent profile and composite biomarker index values using multivariable linear regression, adjusting for socio-demographic, behavioral, metabolic, and HIV-related factors. RESULTS: Among 90 women, 62% were WLWH, 53% were non-Hispanic Black, and median age was 55 years. In full multivariable models, there was no statistically significant association between psychosocial stress and composite biomarker index values among all women independent of HIV status. High (vs. low) psychosocial stress was positively associated with higher mean composite biomarker index values among all monoracial Black women (adjusted ß = 1.32; 95% CI: 0.20-2.43), Black WLWH (adjusted ß = 1.93; 95% CI: 0.02-3.83) and Black HIV-negative women (adjusted ß = 2.54; 95% CI: 0.41-4.67). CONCLUSIONS: Despite a null association in the overall sample, greater psychosocial stress was positively associated with higher neuroendocrine biomarker concentrations among Black women, highlighting a plausible mechanism by which psychosocial stress could contribute to cardiovascular disease risk.

Biological sex differences in Alzheimer's preclinical research: A call to action.

INTRODUCTION: For decades, researchers have largely ignored sex as a biological variable (SABV) within preclinical studies. Recent literature indicates scientists are increasingly including male and female subjects in studies, but fewer studies assess for sex differences in study outcome. This is particularly concerning within the field of Alzheimer's disease (AD), as disease burden is higher among women and evidence suggests sex differences exist in etiology and disease course. METHODS: We conducted an informal review of preclinical AD research studies. RESULTS: Results confirmed that only about one-third of ≈150 recent studies included both male and female mice, and <15 of nearly 150 studies examined SABV as an outcome of interest. DISCUSSION: Previous research supports the idea that better integration of SABV could open new doors in treatment research. We provide examples of best practices and discuss the need for Alzheimer's researchers to account for SABV within preclinical studies.

Monogamy as a Barrier to Human Papillomavirus Catch-Up Vaccination.

Background: Human papillomavirus (HPV) is the most prevalent sexually transmitted infection (STI) in the United States. Although a vaccine to prevent HPV infection exists, only 53.7% of females 13-17 years of age were up-to-date on the HPV vaccination series in 2018. There is a catch-up period of vaccination for females 18-26 years of age that shows consistent underparticipation. A potential barrier to vaccination is relationship status, as long-term relationships may negatively impact HPV risk perception. This study examined monogamy as a risk factor for nonvaccination and explored how risk perception may influence this association. Materials and Methods: An electronic survey was distributed to females 18-26 years of age who attended a large public university in the mid-Atlantic region (n = 629). Multivariable and descriptive statistics were estimated using SAS 9.4 to explore the likelihood of vaccination during the catch-up period by relationship status. Results: Most participants had received the HPV vaccine, a small proportion of whom received it during the catch-up period. After adjusting for confounders, women who were in monogamous relationships were significantly less likely to have participated in HPV catch-up vaccination compared to women who were single and dating (adjusted odds ratio: 0.36, 95% confidence interval: 0.15, 0.87). Women in monogamous relationships had a lower average sexually transmitted disease (STD) risk perception compared to women who were single and dating (p < 0.0001). Conclusions: A decreased risk perception may present a barrier to participating in catch-up vaccination for monogamous women. Practitioners and the public health community should focus on communicating HPV risk to women in monogamous relationships, especially given the recently expanded age range for HPV vaccination.